VNS Therapy?

[NancyB]

I'm a little bit confused. I just got on the Maude Data Base and typed in 1] death caused by Cyberonics vns device-2,360 2] death after vns implant-359 3]Cyberonics vns device causing death-2,680 4] life threatening injury after vns implant-283 5]psychosis after vns implant-21 6] psychiatric hospitalization after vns implant- 33 7] psychiatric hospitalization after Cyberonics vns implant- 29 Then there is another thing that bothers me. Take report# 1644487-2005-00753 10/06/2005 This was with model 102 and was reported by the manufacturer. It said the report was not sent to the FDA, the device was not returned to the manufacturer or available for evaluation and that further follow-up with the treating physician revealed that the death was not believed to be related to the vns system. If the device was not explanted or tested or evaluated, how can they possibly claim that it was not the cause? This is not just one report, either. I am talking report after report of devices that are not being explanted or evaluated and several of these models I've noticed now are on the recall list. I've read P970003 apr# 98M-0140 doc#[P970003S150] In which the post-approval requirements were suppossed to be [among other things] a 460-patient post-market dosing study and a 1,000 patient 5-year registry. Then in a Cyberonics F3Q09 Quarter End 01/23/09 Earnings Call Transcript Daniel Moore is discussing the proposal they submitted to the FDA to change the structure of the TRD post-approval study from 460 patients to 330. I can't understand this. These conditions were given in 2005 to a Class III medical device and in that approval document it very clearly states: FAILURE TO COMPLY WITH ANY POST-APPROVAL REQUIREMENT CONSTITUTES FOR WITHDRAWAL OF APPROVAL OF THE PMA. Obviously that document is just a formality. None of it means anything.

[kimberlymeg]

Wow! That story about your sister is shocking! It definitely makes me even more hesitant to choose surgery as an option. It will be a last resort for me. I've been trying the change in diet for a little while. Since I'm at college its been a little rough but I've taken gluten away and have been taking vitamins. I've been trying to eliminate as many possible triggers as I can. I've been making sure I get atleast seven hours of sleep each night and a nap during the day too. I have actually been extremely tired though. I probably sleep 11-12 hours every day. I don't think I have had any seizures since I came back from christmas break over a week ago . yay for that! I'm not as stressed at school as I was at home over break.

But my spelling has always been super good and now I'm starting to have some problems with that and my speech as well. I'll switch letters in words so that a different word comes out and lately I have frequently been in the middle of saying something and then I can't remember what I was talking about. I have been going into more "staring spells". I'm conscious when it happens but there are days that I have a hard time concentrating on something without zoning out repeatedly. Hopefully things will start to look up.

[NancyB]

Kimberlymeg, I understand every single thing that you have mentioned, because I am exactly the same. One thing that I've noticed, about myself at least, is that the more I think about making sure I DON'T have a seizure, the more I panic and think I'll have one for sure just because of that. One of the keys is try to stay calm. Put yourself in a comfortable position, maybe even put some soothing music on or a favorite t.v. show, and just try to relax. I know I make it sound so easy and simple, but it really does work. If you know you've taken your medicine and all the necessary precautions that you and you're doctor have already discussed, then you'll most likely be fine. Just like I've heard that people can work themselves INTO having a heart attack just by thinking they're going to have one, the same can be true for seizures. Once again, that is what I've found is true with me. Each and every person is different and you know what is best for you. Follow your initial instincts. If nothing else, then you've given yourself a probably much-deserved "time-out", and don't we all deserve that every now and then?

[kimberlymeg]

Thanks, my neurologist did say that my latest eeg showed signs that I was a nervous person haha so I'm not surprised I'm acting like this. I'm actually not on medicine right now and that is why I'm trying to eliminate as much triggers as I can. I'm supposed to do a 24hr EEG before I see my dr again. The second time my seizures started back up, the kind of seizures I had been having had changed and now my dr wants to double check with more tests to make sure that it hasn't changed again. I have yet to find an open apt at his office and space in my schedule with school. So for now I'm pill free. Your right though. I need to try and tell my self to sit back and relax. I went on a missions trip this past weekend and my friends kept making fun of me because I pretty much slept whenever we weren't working. The majority of the pictures from the trip with just me is me sleeping haha.

[NancyB]

Wow! You went on a missions trip? My aunt [my mom's sister] and my uncle, who is a minister who had his church in N.Y. state, were missionaries in Africa, in the Congo, I believe. My cousin and her husband, who is also a minister, are there also. They were there with other missionaries and my mom sent me a book they had published about their work there. When I looked at the pictures in the book I realized how many things I've been taking for granted, like flushing toilets, fresh running water, clean sheets to sleep on and a stove to cook on. I might not live in the Taj Majal, but I have a roof over my head. I know the hard work they had done, so any chance you had to take a nap I'm sure was well deserved.

[dennis100]

6 years post-op I started to experience what I thought were atonic seizures. My parents happened to stop by that morning and became alarmed after witnessing three or four of those episodes. They phoned my neurologist & ems. My last memory of that morning was of being inside of the ambulance. When I regained consciousness I was in the ICU. What was actually happening is the VNS was stopping my heart (asystole) during each of the 30 second stimulation cycles. My device was programmed 30 sec on / 3 min off. I had approx 40 episodes of asystole prior to the device being deactivated. It was a miracle that I survived the ordeal.

If my parents hadn't shown up that morning I would have been just another statistic in the FDA's adverse event database with my death being listed as Sudden Unexplained Death in Epilepsy or UNK. The problem with the VNS is that post-op asystole does occur with the device. Sure the VNS helps some people with seizure control but keep in mind it can also kill you.

[NancyB]

Have you read United States District Court Southern District of Texas Master Filer No. H-05-2121? Now this is some very interesting reading. This was filed 08/17/2006, Case 4:05-cv-02121 Document 54? Now there is some very interesting reading. Page 5, bottom, Blue Cross' Ms. Aronson stated about an initial trial of the VNS device for TRD in which half the patients had the device tuned on, the other not, "This was a well-designed trial that deserves credit. The result showed there was NO DIFFERENCE between the groups.

[NancyB]

Also, on page 15, # 23, it talks about Alan Totah, VP of Regulatory Affairs of Cyberonics, knowing about ADVERSE NON-PUBLIC INFORMATION about the VNS system. On page 20 towards the bottom, it talks about the FDA official who over-rode 20 panel members who did not want the device approved, quoted as saying: 'I think it needs to be stated clearly and unambigiously that {certain VNS data} failed to reach, or even come close to reaching, statistical significance with regard to its primary endpoint.

[NancyB]

I think that one has to conclude that, based on [that] data, either the device has no effect, or if it does have an effect, that in order to measure that effect a longer period of follow-up is required. Further down it talks about the company [Cyberonics] trying to be decietful about the clinical trial data. On page 73: FAILURE TO COMPLETELY INVESTIGATE AND EVALUATE THE CAUSE OF EACH MEDICAL ADVERSE EVENT INCLUDING HIGH LEAD IMPEDANCE, DEVICE MIGRATION, INCREASE IN SEIZURES, AND SUBSEQUENT

[NancyB]

PATIENT DEATH reported in complaint file # 200312-0567 [reference MDR report # 2004-00030] This entire file is quite facinating and will make you wonder just how many other devices are out there that got away with so much.

[Cint]

What was actually happening is the VNS was stopping my heart (asystole) during each of the 30 second stimulation cycles. My device was programmed 30 sec on / 3 min off. I had approx 40 episodes of asystole prior to the device being deactivated. It was a miracle that I survived the ordeal.

If my parents hadn't shown up that morning I would have been just another statistic in the FDA's adverse event database with my death being listed as Sudden Unexplained Death in Epilepsy or UNK. The problem with the VNS is that post-op asystole does occur with the device. Sure the VNS helps some people with seizure control but keep in mind it can also kill you.

From the NeuroCybernetic Prosthesis System NCP Pulse Generator Manual:

PRECAUTIONS
Physicians should inform patients about all potential risks and adverse events
discussed in the NCP System physician’s manuals.
! Laryngeal irritation may result from stimulation. Patients who smoke may
have an increased risk of laryngeal irritation.
! Dyspnea may result from stimulation. Patients with chronic obstructive
pulmonary disease may have an increased risk of dyspnea.
! It is important to follow recommended implantation procedures and
intraoperative product testing described in this manual. During the
intraoperative Lead Test, infrequent incidents of bradycardia and/or asystole have occurred. If asystole, severe bradycardia (heart rate < 40 bpm), or a clinically significant change in heart rate is encountered during a Lead Test or during initiation of stimulation, physicians should be prepared to follow guidelines consistent with Advanced Cardiac Life Support (ACLS). Additionally, postoperative bradycardia can occur among patients with certain underlying cardiac arrhythmias. If a patient has experienced asystole, severe bradycardia (heart rate < 40 bpm) or a clinically significant change in heart rate during a Lead Test at the time of initial device implantation, the patient should be placed on a cardiac monitor during initiation of stimulation.
The safety of this therapy has not been systematically established for patients experiencing bradycardia or asystole during VNS Therapy System
implantation.
! Reversal of lead polarity has been associated with an increased chance of
bradycardia in animal studies. It is important to make sure that the Lead
connector pins are correctly inserted (white marker to + connection) into the Pulse Generator header.
! Do not program the NCP System to an ON or periodic stimulation
treatment for at least 14 days after the initial or replacement
implantation. Failure to observe this precaution may result in patient
discomfort or adverse events.
! Resetting the Pulse Generator turns the device OFF (output current = 0
mA), and all device history information is lost. The device history information should be printed out before resetting.
! It is important to follow infection control procedures. Infections related to
any implanted device are difficult to treat and may require that the device be explanted.

WARNINGS
Physicians should inform patients about all potential risks and adverse events discussed in the NCP System physician’s manuals.
! The safety and efficacy of the NCP System has not been established for uses not covered in the “Intended Use/ Indications” section of this manual.
! The safety and efficacy of the NCP System treatment have not been
established for stimulation of the right vagus nerve or of any other nerve,
muscle, or tissue.
! Excessive stimulation at a combination of high frequency (≥ 50 Hz) and an
excess duty cycle (that is, one that occurs when ON time is greater than OFF
time) has resulted in degenerative nerve damage in laboratory animals. An
excess duty cycle can be produced by continuous or frequent magnet
activation (> 8 hours), as determined by animal studies. Cyberonics
recommends against stimulation at these combinations of ranges.
! Aspiration may result from the increased swallowing difficulties reported by some patients during stimulation. Patients who have pre-existing swallowing difficulties are at greater risk for aspiration.
! Device malfunction could cause painful stimulation or direct current
stimulation. Either event could cause nerve damage and other associated
problems. Patients should be instructed to use the magnet to stop stimulation
if they suspect a malfunction, and then to contact their physician immediately for further evaluation. Prompt surgical intervention may be required if a malfunction occurs.
! Susceptible patients with predisposed cardiac conduction systems (re-entry pathway) have not been studied as part of controlled clinical trials to establish the safety of NCP system treatment in these patients. Evaluation by a cardiologist is recommended if the family history, patient history, or
electrocardiogram suggests an abnormal cardiac conduction pathway. Serum
electrolytes, magnesium, and calcium should be documented before
implantation. Post-implant electrocardiograms and Holter monitoring are
recommended if clinically indicated.
! Sudden unexplained death in epilepsy (Sudden Unexplained Death in Epilepsy): Through August
1996, 10 sudden and unexplained deaths (definite, probable, and
possible) were recorded among the 1,000 patients implanted and treated
with the NCP device. During this period, these patients had accumulated
2,017 patient-years of exposure.

I don't understand why those who have experienced adverse side effects didn't call the neurosurgeon immediately. When I turned blue from not being able to breath from the VNS initially, I was rushed to the hospital and got a breathing treatment, my neurologist was called and she changed the setting of my VNS right then and there.
There are pros and cons to every prescription med, over the counter med, vitamin, device, etc. And for me, the cons are much greater if I went without the VNS or any medication. If it weren't for them, I would probably have been dead by now.

[Birdbomb]

Cint part of the problem is many physicians DON"T know about some of these side effects. Some absolutely refuse to believe the VNS would be at cause. Dennis's asystole was late onset. In fact I have read recently that even if the patient suffers a bradycardia issue during the initial testing, was that the surgeon should just go ahead and implant it anyway. Hey, I know there are some fine and caring doctors and surgeons out there, right on the ball and up to date, but then there are also those who are only in it for the money.

IMHO the injuries and death counts are WAY too high and totally unacceptable. Patients are made to feel like they are making it up, lying, faking or crazy. That's when they start using search engines to find others suffering from the same side effects and then they find my site. They are NOT alone, oh, boy, do they have many others in similar situations!

Some have to go as far as printing out complete threads to PROVE to their doctor, VNS causes problems. Truth in advertising, complete and open disclosure so patients CAN make informed decisions isn't too much to ask for. VNS has saved lives, but it has harmed more than it's helped, and these facts are being kept quiet with clever marketing ploys and the aid of the FDA.

[NancyB]

Many of these doctors ARE being told but they do not except the fact that the vns is causing the problem. My sisters' doctor at first that he had no idea that she was even having a problem with the device, much less in a psychiatric hospital, which I knew was a lie because not only did my parents call him but I did. Then he tried to claim that it wasn't the device, that she had this psychosis thing all along. That's when I told him that anyone with a pre-existing psychosis isn't a suitable candidate for vns and that I was really amazed that a person could work for 20 years as a registered nurse in a hospital with some of the best neurologists and psychiatrists in the country without any of them noticing she was psychotic. They know what the side effects are, they just don't recognize the fact that the device is what's causing them or maybe they just don't want to admit that something they had recommended to someone almost killed them.

[dennis100]

Hi Cint. I was awoken at 2:30 that morning by what I thought was a seizure. The "seizures" continued sporadically through out the early morning hours. By the time my parents arrived at 9:30 the episodes were occurring every 3 minutes. I had no idea that the VNS was the cause of the problem I just thought that I was having another bad day and needed some valium. It took the ER doc & my neurologist approx 20 minutes to realize that the VNS was the culprit.

[Cint]

Many of these doctors ARE being told but they do not except the fact that the vns is causing the problem. My sisters' doctor at first that he had no idea that she was even having a problem with the device, much less in a psychiatric hospital, which I knew was a lie because not only did my parents call him but I did. Then he tried to claim that it wasn't the device, that she had this psychosis thing all along. That's when I told him that anyone with a pre-existing psychosis isn't a suitable candidate for vns and that I was really amazed that a person could work for 20 years as a registered nurse in a hospital with some of the best neurologists and psychiatrists in the country without any of them noticing she was psychotic. They know what the side effects are, they just don't recognize the fact that the device is what's causing them or maybe they just don't want to admit that something they had recommended to someone almost killed them.

I had asked you earlier about this issue: was she taken off all medication immediately after the VNS surgery? If so, then of course, that can make one psychotic as can a certain type of seizures. And I don't understand why, if she was a nurse, did she not ask more questions and why she thought she needed the implant in the 1st place. IMO, anyone who can work a job like that full time, doesn't need to have the surgery in the first place. The seizures must not have been bad if she could work full time back then.

As I stated earlier, the VNS WAS A LAST RESORT for me, after a failed brain surgery! I did not go after the neurosurgeon because the seizures were worse AFTER the lobectomy, as was the depression that made me suicidal. Nor did go after the initial dr. who made the wrong diagnosis right before I was burned in the shower, due to my 1st tonic clonic seizure!
And then, to make matters worse for me, the psyche prescribed a med that made me diabetic, TYPE I, as an adult, so now I have to take insulin shots 4-5 times a day on top of all my seizure meds! I did file a class action lawsuit on that one, and yes, I did win, along with 100's of others in the US and Canada and found out they did take that particular med off the market in Japan. So just because the VNS controls my seizures to some degree, I've had my HELL, too!

[NancyB]

Hi Cint! I just called my sister and asked her if she was still taking meds after the implant and she said yes. She was taking Kepra, Topamox and Lanictol. What's the purpose exactly of the VNS device if you still have to take all those meds?

[Cint]

The original intent for the VNS, I was told way back in 1998, was for those with irretractable epilepsy, like myself, to help abort seizures and decrease some of the meds. It's not a cure all.

[Birdbomb]

Hi Cint! I just called my sister and asked her if she was still taking meds after the implant and she said yes. She was taking Kepra, Topamox and Lanictol. What's the purpose exactly of the VNS device if you still have to take all those meds?

It's ADJUNCTIVE therapy. Meant to be used with meds. But just a few lucky ones can reduce their medications or stop them completely. I never was one of the lucky ones, I had to keep changing the settings and medications until it was no longer compatible with my body.

[Cint]

It's ADJUNCTIVE therapy. Meant to be used with meds. But just a few lucky ones can reduce their medications or stop them completely. I never was one of the lucky ones, I had to keep changing the settings and medications until it was no longer compatible with my body.

This is what I just said in my previous reply.
It was used as an adjunctive therapy AFTER BRAIN SURGERY + NUMEROUS MEDICATIONS for me!! I was never one of the lucky ones to find relief through brain surgery, meds, or the VNS, even after changing the settings numerous times, and having it on rapid cycling. Didn't you and Nancy's sister find relief from seizures through a medication? If so, why in the world did you try the VNS in the 1st place? Not all of us are seizure-free, after being to HELL and back!

[NancyB]

My sister wanted an added assurance that she was given of the vns device that her seizures would be so under control that she could live a life as close to normal as she could get. I don't thing she ever really imagined that this device was actually capable of doing just the oppisite and worse. Even if she ever had a seizure on the medication she's on now, I don't think she'll ever have to worry again about dying from it.